国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
ciprofloxacin, Quantity: 2 mg/mL; hydrocortisone, Quantity: 10 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Ciprofloxacin,Hydrocortisone
Ear Drops, suspension
Excipient Ingredients: polysorbate 20; sodium acetate; glacial acetic acid; benzyl alcohol; hydrogenated soy phosphatidylcholine; sodium chloride; polyvinyl alcohol; purified water
Otic
10mL
(S4) Prescription Only Medicine
For the treatment of acute bacterial otitis externa, caused by organisms susceptible to ciprofloxacin (see PHARMACOLOGY), in adults and children aged 2 years and older.
Visual Identification: Slightly viscous white to off-white opaque suspension with acetous odour.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-03-12
CIPROXIN ® HC 1 CIPROXIN ® HC _EAR DROPS _ _Ciprofloxacin and Hydrocortisone _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Ciproxin HC Ear Drops. This leaflet answers some common questions about Ciproxin HC Ear Drops. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Ciproxin HC against the risks this medicine could have for you. The information in this leaflet applies to Ciproxin HC only. This information does not apply to similar products, even if they contain the same ingredients. If you have any concerns about using this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CIPROXIN HC IS USED FOR Ciproxin HC is used to treat an infection of the outer ear caused by bacteria. This condition is known as bacterial otitis externa. It may cause itching or pain. Ciproxin HC contains two active ingredients: Ciprofloxacin; a "fluoroquinolone" antibiotic which kills the bacteria causing the infection. Hydrocortisone; a corticosteroid that reduces the pain, redness and/or inflammation. Ciproxin HC will not work against infections caused by viruses, such as colds or the flu, or infections caused by fungus. Before prescribing Ciproxin HC for you or your child, your doctor will have examined the ears and decided that Ciproxin HC is the right medicine. Your doctor may have prescribed Cipro 完全なドキュメントを読む
1 AUSTRALIAN PRODUCT INFORMATION – CIPROXIN® HC (CIPROFLOXACIN AND HYDROCORTISONE) EAR DROPS 1 NAME OF THE MEDICINE Ciprofloxacin hydrochloride and Hydrocortisone. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CIPROXIN HC Ear Drops contains 2.33 mg/mL ciprofloxacin hydrochloride (corresponding to 2.0 mg/mL ciprofloxacin), 10 mg/mL hydrocortisone and 9.0 mg/mL benzyl alcohol as preservative. CIPROXIN HC Ear Drops contain benzyl alcohol as a preservative. Other excipients are: polysorbate 20, sodium acetate, acetic acid-glacial, sodium chloride, hydrogenated soy phosphatidylcholine, polyvinyl alcohol, water-purified. CIPROXIN HC Ear Drops contain soya bean products. 3 PHARMACEUTICAL FORM CIPROXIN HC Ear Drops is supplied as a non-sterile, slightly viscous white to off-white opaque suspension in a 10 mL bottle with acetous odour with a separately wrapped non-sterile dropper assembly. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CIPROXIN HC Ear Drops are indicated for the treatment of acute bacterial otitis externa, caused by organisms susceptible to ciprofloxacin (see PHARMACOLOGY), in adults and children aged 2 years and older. 4.2 D OSE AND METHOD OF ADMINISTRATION FOR CHILDREN (AGE 2 AND OLDER) AND ADULTS Three drops of the suspension (equivalent to about 0.09 mL CIPROXIN HC Ear Drops containing 0.18 mg ciprofloxacin and 0.9 mg hydrocortisone) should be instilled into the affected ear twice daily for seven days. The bottle should be shaken well, immediately before use. The patient should be either sitting or lying down with the affected ear turned upwards and then the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the external ear canal. Repeat if necessary, for the opposite ear. USE IN ELDERLY No specific limitation. USE IN CHILDREN For children less than 2 years of age, there is insufficient data available. 2 USE IN HEPATIC IMPAIRMENT No specific limitation. USE IN RENAL IMPAIRMENT No specific limitation. 4.3 C ONTRAINDICATIONS 完全なドキュメントを読む